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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-97306 |
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RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
OBJECTIVES:
Primary
OUTLINE: Patients undergo a positron emission tomography-computed tomography (PET-CT) scan within 90 days before surgery. Beginning 1-4 hours before surgery on day 1, patients receive an injection of fludeoxyglucose F 18 (FDG) and a mediastinoscopy is performed. FDG-avid lymph nodes are obtained and may undergo immunohistochemical analysis or standard analysis. Patients with mediastinal lymph node micrometastasis do not undergo primary tumor resection. Patients with ipsilateral mediastinal micrometastases undergo neoadjuvant chemotherapy prior to surgical resection. Patients with contralateral mediastinal micrometastases undergo definitive chemoradiotherapy. In the absence of mediastinal lymph node metastases (micro or macro), complete surgical resection is performed after the mediastinoscopy, including complete thoracic lymphadenectomy. The tumor and lymph nodes (both from mediastinoscopy and thoracotomy) undergo radioactivity measurements with the hand-held gamma probe. Fresh tumor and lymph node samples are stored for future studies.
Patients complete the Short Form 36 Health Survey (SF-36) before surgery and at 1, 3, and 6 months after surgery to assess the potential impact of the gamma probe on patient quality of life.
After completion of study, patients are followed every 6 months for 2 years, and then annually for 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy | Drug | Given IV and Orally | ||
| lymphadenectomy | Procedure | Removal of lymph nodes | ||
| neoadjuvant therapy | Procedure | Tumor reduction | ||
| quality-of-life assessment | Procedure | Correlative Study | ||
| therapeutic conventional surgery | Procedure | Treatment for cancer | ||
| thoracic surgical procedure | Procedure | removal of tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate at 2 years | 2 years | |
| Recurrence rate at 2 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Positive threshold of lymph node radioactivity | within 90 days | |
| Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe | Within 90 days |
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DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
Planning to undergo surgical resection
No tumors that are not fludeoxyglucose F 18 (FDG)-avid on PET scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Chukwumere E. Nwogu, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| fludeoxyglucose F 18 | Radiation | given IV |
| radiation therapy | Radiation | undergoing radiotherapy |
| Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging | Within 90 days |
| Quality of life | At 3 years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D008197 | Lymph Node Excision |
| D020360 | Neoadjuvant Therapy |
| D019616 | Thoracic Surgical Procedures |
| D019788 | Fluorodeoxyglucose F18 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D003131 | Combined Modality Therapy |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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